Condition category
Nervous System Diseases
Date applied
01/09/2005
Date assigned
01/09/2005
Last edited
08/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lionel Carmant

ORCID ID

Contact details

Service de Neurologie
Hôpital Sainte-Justine
3175 Chemin de la Côte Ste-Catherine
Montréal
Quebec
H3T 1C5
Canada
+1 514 345 4931 (6106)
lionel.carmant@umontreal.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-53573

Study information

Scientific title

Acronym

Study hypothesis

To determine whether infants and children receiving the Infantile Spasms (IS) standard therapy as well as Flunarizine will have an improved developmental outcome as compared to that of children receiving the same treatment with a placebo.

Ethics approval

Ethics approval received from the Hôpital Sainte-Justine, Comité d'éthique de la recherche on the 15th July 2004.

Study design

Randomised double blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Infantile Spasms (IS)

Intervention

All infants and children will receive initial IS conventional therapy, consisting of Vigabatrin (VGB) administration (as well as vitamin B6), followed after a two week period by Adrenocorticotropic Hormone (ACTH - Synacthen) treatment, if no IS cessation or amelioration occurs. Moreover, if the infants’ or children's' IS still do not respond to the latter hormone, they may be treated with Topiramate.

Besides the standard IS treatment, Flunarizine or placebo will be administered from the onset of the study for a total of six months in order to determine its efficacy in preventing or ameliorating the mental deterioration associated with IS. After this time, all treatment will be ceased.

Following cessation of treatment, the neurological and neuro-psychological status of infants and children will still be followed for an additional one and one half year period to determine their long-term response to Flunarizine (and to placebo) and to assess their mental development.

Intervention type

Drug

Phase

Not Specified

Drug names

Flunarizine, vigabatrin, synacthen, topiramate

Primary outcome measures

Intelligence Quotient (IQ) scores are evaluated with Bayley scales at time 0 and 24 months.

Secondary outcome measures

1. Autistic behaviour
2. Longitudinal development and pattern of developmental progress in infants and children
3. Occurrence of IS

Overall trial start date

01/04/2002

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 3 - 18 months, either sex, with new onset infantile spasms
2. Electroencephalogram (EEG) showing hypsarrhythmia or modified hypsarrhythmia
3. Children not receiving treatment for infantile spasms at the time of the initial visit, i.e. vigabatrin or synacthen
4. Parents or legal guardian agree to sign the consent form

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Age under 3 months or over 18 months at onset of spasms
2. Degenerative neurological disorder because their relentless course toward a poor outcome regardless of therapeutic interventions would limit the possibility of generalising our findings to all children with infantile spasms
3. Pre-existing medical condition where steroids would be contraindicated
4. Families unable to comply with follow-up visits or agree to informed consent

Recruitment start date

01/04/2002

Recruitment end date

31/03/2006

Locations

Countries of recruitment

Canada

Trial participating centre

Service de Neurologie
Montréal, Quebec
H3T 1C5
Canada

Sponsor information

Organisation

Hôpital Sainte-Justine (Montréal) (Canada)

Sponsor details

3175 chemin Côte Ste-Catherine
Montréal
Quebec
H3T 1C5
Canada

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-53573)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes